Prevention of Perioperative Acute Renal Failure

This study has been terminated.
(An external board recommended to close the study for futility after the interin analysis)
Sponsor:
Collaborator:
Fondo de Investigacion Sanitaria
Information provided by:
Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier:
NCT00953940
First received: August 4, 2009
Last updated: June 30, 2011
Last verified: August 2009
  Purpose

The purpose of this study is to measure the acute renal dysfunction on the first, second, seventh and twentieth days.


Condition Intervention Phase
Abdominal Surgery
Drug: Isotonic saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Perioperative Acute Renal Failure in Abdominal Surgery

Further study details as provided by Hospital Universitario Ramon y Cajal:

Primary Outcome Measures:
  • Serum creatinine in the first, second, seventh and twenty after surgery in patients undergoing elective abdominal surgery. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: June 2005
Study Completion Date: May 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Isotonic saline
Isotonic saline
Drug: Isotonic saline
Isotonic saline administrated i.v at 1.5 ml/Kg/h , 8 to 12 h before surgery
No Intervention: No treatment
Habitual therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients who are undergoing elective abdominal surgery after appropriate information of the study, and its possible risks that may arise therefrom and that at any time to refuse their cooperation, give a written consent to participate in the study.
  • Patients who at the time of the interview have an ASA between 2 and 4.
  • Patients with chronic kidney failure mild moderate (serum creatinine between 1.5 and 3.0 mg / dl) can be included.

Exclusion Criteria:

  • Chronic kidney diseases with serum creatinine higher than 3.0 mg /DL
  • Laparoscopic abdominal surgery
  • ASA 1 and ASA 5 patients.
  • Patients with cardiac insufficiency, ascites and respiratory insufficiency
  • Diastolic hypertension > 100 mmHg
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00953940

Locations
Spain
Hospital Ramon y Cajal
Madrid, Spain, 28034
Sponsors and Collaborators
Hospital Universitario Ramon y Cajal
Fondo de Investigacion Sanitaria
Investigators
Principal Investigator: Dr Fernando Liaño, MD PhD Hospital Universitario Ramon y Cajal
  More Information

No publications provided

Responsible Party: Fernando Liaño García, Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier: NCT00953940     History of Changes
Other Study ID Numbers: Nefrane001, NºEudra CT: 2005-004755-35
Study First Received: August 4, 2009
Last Updated: June 30, 2011
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Renal Insufficiency
Acute Kidney Injury
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014